- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03339687
Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Research Group RISKDYNAMICS, Sub-Project 8, Work Package 1, Study 2: Addiction Risk: The Influence of Mindset Induction on the Effect of a Brief Intervention to Reduce Alcohol Use
Brief Interventions (BI) based on Motivational Interviewing are effective to reduce alcohol use. In this study the investigators test the hypothesis that that an open Mindset increases the positive effects of BI.
Patients who are newly admitted to the psychotherapy outpatient clinic are routinely screened for risky alcohol use. All patients with risky alcohol use are eligible to the study and all receive the WHO's ASSIST-linked BI.
Participants receive a brief Mindset induction prior to receiving BI. They are are randomly assigned to either the induction of an open or a closed Mindset according to Gollwitzer.
The investigators measure the change in alcohol-related risk perception, treatment motivation and real alcohol drinking.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konstanz, Germany, 78464
- University of Konstanz, Psychotherapy Outpatient Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- admitted to treatment at psychotherapy outpatient clinic
Exclusion Criteria:
- alcohol use disorder
- substance use disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Induction of Open Mindset
Psychological Intervention.
Participants are asked to work on a brief paper-and-pencil task that has been shown to induce a Deliberative Mindset according to the Mindset theory of action phases (Gollwitzer & Keller (2016).
Mindset Theory.
In: V. Zeigler-Hill, T.K. Shackelford (eds.),
Encyclopedia of Personality and Individual Differences.
New York: Springer).
|
This induction of a psychological state was extensively studied in cognitive science. Gollwitzer & Keller (2016, p.3): "The deliberative mindset is evoked by asking participants to (a) name an unresolved, important personal problem that is causing rumination but for which they have not made a decision yet and (b) reflect on whether to take action or not. Further, to enhance the depth of reflection, participants are requested to list positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required. The implemental mindset is evoked by asking participants to think of a personal project for which they have already made the decision to act but did not initiate any action yet. Subsequently, participants are asked to list the steps necessary for successful goal attainment and to plan out in detail when, where, and how they intend to act on each of these steps." |
Experimental: Induction of a Closed Mindset
Psychological Intervention.
Participants are asked to work on a brief paper-and-pencil task that has been shown to induce an Implemental Mindset according to the Mindset theory of action phases (Gollwitzer & Keller (2016).
Mindset Theory.
In: V. Zeigler-Hill, T.K. Shackelford (eds.),
Encyclopedia of Personality and Individual Differences.
New York: Springer).
|
This induction of a psychological state was extensively studied in cognitive science. Gollwitzer & Keller (2016, p.3): "The deliberative mindset is evoked by asking participants to (a) name an unresolved, important personal problem that is causing rumination but for which they have not made a decision yet and (b) reflect on whether to take action or not. Further, to enhance the depth of reflection, participants are requested to list positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required. The implemental mindset is evoked by asking participants to think of a personal project for which they have already made the decision to act but did not initiate any action yet. Subsequently, participants are asked to list the steps necessary for successful goal attainment and to plan out in detail when, where, and how they intend to act on each of these steps." |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual Risk Perception
Time Frame: The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
|
The participant's self-reported risk of experiencing alcohol-related problems is measured with the self-report measure "Questionnaire for Alcohol-related Risk Perception" (German "Fragebogen zur Alkoholbezogenen Risikowahrnehmung", FAR; Klepper, Odenwald & Rockstroh (2016).
Risikowahrnehmung und Alkoholabhängigkeit. SUCHT, 62 (6), 374-382; DOI 10.1024/0939-5911/a000457).
|
The questionnaire assesses the variable related to the week before, i.e. time frame 1 week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of alcohol drinking
Time Frame: The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
|
Self-reported amount of standard units of alcohol consumed by the individual
|
The interviewers assess the number of standard units of alcohol consumed during month before assessment, i.e. time-frame 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OD 113/2-1(2)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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